As the entire world is aware at this point, on the 1st January 2021, the United Kingdom left the European Union single market and became, in effect, a ‘third country’.
As it happens an EU regulation, Regulation (EU) 2019/1020, comes into force on the 16th July 2021 and introduces a substantial change for UK manufacturers importing into the European Union. The regulation requires one of the following – Importer, Authorised Representative or Fulfilment service provider – to be appointed on their behalf and located within the EU.
The Regulation makes it illegal to place certain products on the EU market unless the above is complied with. Manufacturers that currently sell, or offer to sell, directly to end users in the EU must appoint one of the above before selling, or attempting to sell, any further products in the EU.
What is an Authorised Representative?
An ‘authorised representative’ is defined in European Union law as:
“any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;”
As such, an Authorised Representative is required to perform at least the following functions, but can provide additional services if they are agreed as between the parties:
- Keep the Declaration of Conformity and the technical documentation at the disposal of the Market Surveillance Authorities;
- Cooperate with the authorities in the event that enforcement action is mounted against the manufacturer;
- Perform any other tasks identified in the written mandate agreed between the Authorised Representative and the manufacturer.
Authorised Representative – Why appoint one?
Most manufacturers will probably want to appoint an Authorised Representative, rather than rely on their importer, for the following reasons:
- they may not want their importer to see all their technical documentation in the event of a Market Surveillance Authorities action;
- their importer may be reluctant to be put in a position where they have to deal with an Market Surveillance Authorities action;
- a manufacturer may have several importers and each will need to have their name and address on the units which they have imported. Appointing an AR could mean that only one address is required;
- EU importers will generally be much happier to trade with a non-EU manufacturer who has appointed an AR to specifically handle regulatory responsibilities.
What to consider in selecting your Authorised Representative
One of the most important things to consider when appointing an Authorised Representative to represent you in the European Union, is defining what precisely the representative is offering to do.
In particular, the requirement for the representative to ‘co-operate with the regulator’ unless well defined, may well result in having to engage a third party, such as a local legal representative, to represent your interests with the regulator, if the Authorised Representative appointed is either unable or unwilling to do so.
The mandate signed as between the parties should be as explicit as possible as to how the parties will behave in the event of an audit by a Market Surveillance Authorities, or multiple authorities.
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The material contained in this post is for general information purposes only and does not constitute legal advice. Specific legal advice should be sought on any particular matter. No liability whatsoever is accepted by PF Solicitors for any action taken in reliance on the information in this post.